Clinical Research Associate - Midrand at MSD

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The role acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as Subject Matter Expert for monitoring processes and systems.

Qualifications, Skills & Experience:

CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH and country clinical research law and guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action

Experience Requirements:

Required:

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

• B.A./B.Sc. with strong emphasis in science and/or biology